Regulations impacting product lifecycle management (PLM) vary by region and industry. Below are the most common product lifecycle industry/government requirements and guidelines:
- ISO 9001: Requirements for quality management systems and ensuring products meet regulatory requirements.
- ISO 14001: Guidelines for environmental management systems that aim to reduce environmental impacts throughout the product lifecycle.
- ISO 31000: Risk management principles and guidelines for throughout the product lifecycle.
- ISO 13485: Quality management system requirements specific to the design and manufacture of medical device products.
- ISO 27001 / IEC 27001: Standards for information security management for sensitive company info throughout the product lifecycle.
- AS9100: Quality management requirements specific to the design and manufacture of aerospace industry products.
- 21 CFR Part 820: US FDA regulations regarding lifecycle management for pharmaceuticals and medical devices.
- REACH (Registration, Evaluation, Authorization, Restriction of Chemicals): Restricting the use of specific hazardous materials found in electrical and electronic products.
- GDPR (General Data Protection Regulation): EU data protection and privacy rules apply to PLM systems that handle personal data.
- ITAR (International Traffic in Arms Regulations) and EAR (Export Administration Regulations): US regulations for the import and export of defense-related and dual-use items.
- SAE Standards: Society of Automotive Engineers standards for PLM in the automotive and aerospace industries.